Feasibility of Integrating Homeopathic Approach in a Comprehensive Cancer Center

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2028-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Supportive and palliative care play an important role in cancer treatment, and when introduced early can improve quality of life and may even increase median survival rates, as shown in patients with advanced lung cancer. Complementary and integrative medicine (CIM) is a popular supportive approach among oncology patients and is on the rise worldwide. In many countries, homeopathy is being one the CIM methods integrated with a general sense that this treatment is beneficial to the well-being and quality of life (QoL) of cancer patients. In this observational study we will evaluate the feasibility of integrating homeopathic approach in patients attending the complementary and integrative oncology service at the division of oncology in Rambam Health Campus in Haifa, Israel, a major referral comprehensive cancer center.

This observational study will evaluate three main ingredients of acceptance:

* Obtaining the reasons that patients willing to integrate this supportive approach
* Patient acceptance of this supportive approach as well as compliance with the homeopathic approach
* Obtaining retrospective subjective information from the patients through validated quality of life questionnaires. (MYCaW, Distress Thermometer, and ESAS-R) Measures which are used routinely in integrative oncology encounters.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Questionnaires of Tumor Patients With and Without Additive Homeopathic Therapy

NCT00861432

Tumor

COMPLETED PHASE2

Measuring Concerns of Cancer Patients Referred to Complementary Medicine Treatment Integrated Within Oncology Service

NCT01860365

Quality of Life

RECRUITING NA

Impact of Acupuncture and Manual Therapies on Patients' Quality-of-life in a Hospital-to-community Continuum

NCT06590766

Oncology

RECRUITING NA

Integrative Care Training Program for Nurses on Supportive Cancer Care

NCT03676153

Cancer Quality of Life Nurse's Role

COMPLETED NA

HRQoL in Advanced Soft Tissue Sarcoma Patients Treated With Chemotherapy.

NCT03621332

Quality of Life

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Supportive and palliative care play an important role in cancer treatment, and when introduced early can improve quality of life and may even increase median survival rates, as shown in patients with advanced lung cancer.

Complementary and integrative medicine (CIM) is a popular supportive approach among oncology patients and is on the rise worldwide. As a response to this demand, there is an understanding that these approaches need to be integrated in cancer care. In 90% of large comprehensive cancer centers in the US and in many others in Europe and elsewhere, complementary and integrative medicine is being integrated into supportive patient care.

In Israel similar trend is observed and 8 integrative oncology services has been established around the country in the majority of oncology centers. Homeopathy is one of the CIM modalities utilized by patients with cancer. It is widely practiced worldwide, especially in Europe, Asia, and Latin America.

In the United States, during the 1990s, sales of homeopathic medicines grew at an annual rate of 20-25%, and in the 2015 US National health statistics report, homeopathy was mentioned as used by over 5 million people.

This modality involves detailed interview that emphasizes the unique characteristics of symptoms experienced by patients followed by utilizing highly diluted substances. Dilutions that are above 12c (dilution of 10-24 actually do not have the original substance), which are commonly used in homeopathy, reflect that the original material is not in this remedy. As a result of this understanding this complementary therapy remains one of the debated modalities in CIM.

Some mention that patients seek that method of care due to the fact that this approach emphasizes empathic listening to patients' concerns and worries, and the effect of the actual remedy, due to its high dilution, reflect a placebo response.

On the other hand, some clinical studies reveal that the use of homeopathy in cancer care, as a supportive approach, reflects clinical benefit that is not attributed to placebo, without risk of side effects or interactions with the conventional oncology approach.

In one prospective observational study done in Germany with cancer patients in two differently treated cohorts: one cohort with patients under complementary homeopathic treatment (n = 259), and one cohort with conventionally treated cancer patients (n = 380). It was observed that an improvement in quality of life was observed in patients taking the addition of homeopathic treatment, as well as a tendency of fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment.

Another recent descriptive study that was conducted in France in three oncology centers in one city. Researchers observed that homeopathy was used in 30% of the cancer patients. (n=633) The homeopathy was used as an additional supportive measure. Fatigue was one of the leading symptoms that improved in 80% of the patients that homeopathy was added to their care.

An Israeli study evaluated the adherence to homeopathic treatment among cancer patients who received a CIM consultation (n=124). The authors found that homeopathy treatment was feasible, with two-thirds of patients acquiring and self-administering the remedies as prescribed. Fatigue was one of the main symptoms that patients felt that improved with the addition of homeopathy.

In another prospective, randomized, placebo-controlled, double-blind, three-arm, multicenter, phase III study at the University of Vienna, researchers evaluated the possible effects of additive homeopathic treatment compared with placebo in 150 patients with stage IV Non-Small Cell Lung Cancer (NSCLC). Researchers found that there was a significant improvement of quality of life measures in the additive homeopathy group when compared with placebo after 9 and 18 weeks of homeopathic treatment. In addition, median survival time was significantly longer in the homeopathy group (435 days) versus placebo (257 days; p = .010) as well as, versus control (228 days; p \< .001).

Homeopathy is considered safe and without adverse effects, neither direct (i.e., toxic effects) nor indirect (i.e., interactions with conventional anticancer agents).

In this study, patients affected by cancer that attend the oncology department in Rambam Health Campus, and wish to utilize the CIM service, will be offered this option of care.

The aim of the present study is therefore to evaluate the feasibility of the process of integrating homeopathy as a potential treatment option for symptom control and improvement in quality of life in cancer patients, in a comprehensive cancer center.

This observational study will evaluate three main ingredients:

* Obtaining main concerns of patients that agree to utilize this method
* Patient acceptance of this supportive approach that will be reflected in obtaining and self-administering the remedies as prescribed.
* Obtaining retrospective subjective information from the patients through validated quality of life questionnaires. (MYCaW, Distress Thermometer, and ESAS-R) Measures which are used routinely in integrative oncology encounters, at the initial evaluation, and during follow up visits.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Quality of Life Complementary Medicine Integrative Medicine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Feasibility of a supportive approach

Evaluating a feasibility of an approach

Feasibility of a supportive approach

Intervention Type BEHAVIORAL

Evaluating reasons for patients to use the approach

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Feasibility of a supportive approach

Evaluating reasons for patients to use the approach

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • 18 years of age or older

* Ability to read, write, and understand the Hebrew language
* Patients treated at the Division of Oncology in Rambam Health Campus.
* Performance status of ECOG 0-2.
* Consent to participate in the study.

Exclusion Criteria

* • Inability to understand the intent of the study and follow the instructions

* Diagnosis of active psychosis, altered mental state or severe cognitive impairment confirmed by the patient's attending physician.
* Frailty, ECOG worse than 2, or other unstable medical conditions as confirmed by the patient's attending physician including acute illness, fever, unclear rash or medical conditions that would preclude participation in an interview session lasting 15-30 minutes

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No